Idarucizumab: Additional Phase III data

Data from 39 patients with elevated anticoagulation levels at baseline who were treated with Pradaxa dabigatran etexilate and who required emergency surgery or an invasive procedure in the open-label, international Phase III RE-VERSE AD trial showed that the median time between administration of 5 g IV idarucizumab -- given as two 2.5 g bolus infusions <15 minutes apart -- and surgery was 1.7 hours. Normal blood clotting during surgery was reported in 92% of patients and there were no post-surgical bleeding complications reported in the 24 hours following surgery. Six patients died within 2 days of the emergency procedure and 3 additional patients died during the 90-day follow-up period. Boehringer said that mortality within 96 hours of study enrollment appeared to be related to the original reason for emergency admission to the hospital, while all later events appeared to be related to co-morbidities. Two patients suffered a thromboembolic event on days 7 and 26 post-surgery, respectively, but both patients were not receiving antithrombotic therapy at the time. The analysis included patients whose surgery could not be delayed for >8 hours. The trial is slated to enroll up to 300 patients. Data were presented at the European Society of Cardiology meeting in London. ...